đź“‹ FDA Reference
neer-iii osteoarthritis glenoid resurface prosthe
Kirschner Medical
Summary: The Neer-III Osteoarthritis Glenoid Resurface Prosthe is a medical device used in orthopedic surgery to resurface the glenoid in patients with osteoarthritis. It is typically used by orthopedic surgeons specializing in shoulder procedures.
FDA Clearance Information
Pathway
510K
Number
K873620 ↗
Decision Date
October 15, 1987
Product Code
KWT
Device Class
Class 2
Evidence
0 studies
The Neer-III Osteoarthritis Glenoid Resurface Prosthe was cleared through the FDA 510k pathway on October 15, 1987. Manufactured by Kirschner Medical, it is classified as a Class 2 device under product code KWT.
What It Is
The Neer-III Osteoarthritis Glenoid Resurface Prosthe is a prosthetic device designed to resurface the glenoid cavity of the shoulder joint in patients suffering from osteoarthritis. This device helps restore joint function and alleviate pain by providing a smooth surface for the humeral head to articulate against. It is typically made from biocompatible materials that ensure durability and compatibility with the body's tissues.
Clinical Applications
This device is commonly used in orthopedic surgical procedures aimed at treating shoulder osteoarthritis. It is particularly relevant in cases where conservative treatments have failed, and surgical intervention is necessary to restore joint function. Orthopedic surgeons, especially those specializing in shoulder and upper extremity surgery, use this device in hospital or outpatient surgical settings. The typical patient population includes older adults with advanced osteoarthritis of the shoulder.
Indications for Use
The FDA indications for this device include resurfacing the glenoid cavity in patients with osteoarthritis of the shoulder. It is intended for patients who experience significant pain and reduced mobility due to joint degeneration.
Practical Considerations
When considering this device, clinicians should note the typical sizing options available to accommodate different patient anatomies. It is important to ensure compatibility with the patient's existing shoulder anatomy and any other prosthetic components. Surgical technique considerations include ensuring proper alignment and fixation of the prosthetic to optimize outcomes.
Frequently Asked Questions
What is Neer-III Osteoarthritis Glenoid Resurface Prosthe used for?
It is used to resurface the glenoid cavity in patients with shoulder osteoarthritis to restore joint function and reduce pain.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in shoulder and upper extremity surgery, typically use this device.
What are the FDA-cleared indications?
The device is indicated for resurfacing the glenoid cavity in patients with osteoarthritis of the shoulder.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.